Why Gold Could Retain its Luster

Gold’s Appeal is Driven by More than Coronavirus Fears

(Note: companies that could be impacted by the content of this article are listed at the base of the story [desktop version]. This article uses third-party references to provide a bullish, bearish, and balanced point of view; sources are listed after the Balanced section.) 

Year-to-date through March 4, 2020, gold futures prices have risen 7.0%, following a gain of 16.5% in 2019.  Most recently, gold prices have responded to the economic risks posed by the Coronavirus 2019 (Covid-19) and ensuing market volatility and uncertainty that has followed the virus’s spread globally.  However, many believe that gold has a host of macroeconomic and market factors working in its favor.  These include the path of real interest rates, the outlook for U.S. dollar strength relative to other currencies, balance of trade and U.S. government fiscal policies; all of which influence the price of gold. 

With the rise in precious metals prices, mining stocks may be an attractive way to gain exposure to silver and gold given the disproportionate percentage impact higher commodity prices may have on a company’s bottom line and valuation for a given percentage increase in the commodity itself. 

While past pandemics such as Severe Acute Respiratory Syndrome (SARS) in 2003, H1N1 Influenza Virus (Swine Flu) in 2009, Middle East Respiratory Syndrome (MERS) in 2012 have acted as short term catalysts for gold prices when investors sought safe haven assets, investors should view longer-term fundamentals when evaluating precious metals investments.   

The Case for Gold Investments:

Pandemic threats enhance gold’s appeal.  During past pandemics, gold prices benefited as investors turned to precious metals for a haven.      

Lower interest rates are supportive of gold prices.  On March 3, 2020, the Federal Open Market Committee lowered the target rate for the federal funds rate by 50 basis points to a range of 1.0% to 1.25%.  The action was taken to counter risks to economic activity posed by the spread of the Coronavirus.

Increasing government deficits and debt.  According to the Congressional Budget Office, the U.S. government’s public debt is now greater than $22 trillion, its highest level in history.  According to the U.S. Treasury Department, the deficit amounted to $984.4 million in fiscal year 2019 and was $398.2 through January of fiscal year 2020.  The government’s fiscal year begins in October.  The Congressional Budget Office projects the federal budget deficit will be $1.0 trillion in 2020 and average $1.3 trillion between 2021 and 2030, representing 4.6% of gross domestic product in 2020 to 5.4% in 2030.  

Looking out for the next recession.  Precious metals equities may provide a hedge against volatility in the equity markets and offer diversification benefits.  Many believe the bull market that began in 2009 is in its late innings and a recession could be just around the corner.  These concerns have only been magnified by the coronavirus’ impact on economic activity which is well documented.  Travel has been slowed, global supply chains have been disrupted and to date, the virus is still spreading globally.   

The Case for Non-Gold Assets :

Coronavirus will be contained.  Like past epidemics and/or pandemics, massive resources on multiple fronts are aimed at containing such health threats.  If past epidemics are any indication, the coronavirus will be eventually contained although the timing is uncertain.       

Better than expected economic growth.  With the U.S. Presidential election on the horizon, the Trump administration is doing everything in their power to maintain economic growth and the health of the stock market.  The Federal Reserve has already stepped up and the government has ample means at its disposal (i.e., spending) to stimulate the economy.  Therefore, the economy could get past the coronavirus and worries about a recession could recede.   

Dollar retains its strength relative to other currencies.  Despite rising government deficits and debt along with relatively low interest rates, the dollar has remained relatively strong.  With recent trade frictions and global instability, the dollar has benefited from a flight to quality as other countries   

Big Picture:

Gold prices will likely hold recent gains and/or move higher as investors increasingly include gold as part of a well-diversified portfolio.  While fears of global pandemics often lead investors to seek safe-haven investments, the impacts can be short-lived depending on their longer-term economic impacts.  With the coronavirus, it likely intensifies many of the factors that are already supportive of gold prices, including lower interest rates, worries about global economic growth and increased government spending.  Rather than relying on short-term drivers of precious metals prices, investors should evaluate longer-term fundamentals and reap the benefits of diversification with investments in precious metals mining equities and/or bullion.

Sources:

Monthly
Treasury Statement, Receipts and Outlays of the United States Government, For
Fiscal Year 2020 through January 31, 2020
, U.S. Department of the Treasury, January 2020.

The
Budget and Economic Outlook: 2020 to 2030
, Congressional Budget Office, January 2020. 

Is
Investing in Gold Worth It In 2020
, Forbes, Tyler Gallagher, March 3, 2020.

 Coronavirus
Epidemic Emphasizes the Need to Buy Gold
, CCN, Ayush Singh, January 22, 2020.

The
Coronavirus:  Killer Bug and Economic
Pandemic
, Red Rock Secured, Sean Kelly, March 4, 2020.

Here’s
the Investment Strategy Bridgewater’s Ray Dalio is Using to Deal with the
Coronavirus
, Cnbc, Patti Domm, January 30, 2020.

The Business of Mass-Producing Vaccines

Dyadic CEO Discusses how his Company Could Expedite Vaccine Production

(Note: companies that
could be impacted by the content of this article are listed at the base of the
story [desktop version]. This article uses third-party references to provide a
bullish, bearish, and balanced point of view; sources are listed after the
Balanced section.)

In an interview, Dyadic CEO Mark Emalfarb told Trish Regan of FOX Business News that his company has the technology to allow them to mass-produce a vaccine should one get approved. “We developed the technology platform that we’ve been developing for years over two and half decades to make proteins at large scale, at very low cost,” Emalfarb said. Watch
Video

Research – Dyadic International Inc. (DYAI) – Progress and Efforts Continues to Validate C1 Platform

Wednesday, February 26, 2020

Dyadic International Inc. (DYAI)

Progress and Efforts Continues to Validate C1 Platform

Dyadic International, Inc. is a global biotechnology company which is developing what it believes will be a potentially significant biopharmaceutical gene expression platform based on the industrially proven hyper productive engineered fungus Thermothelomyces heterothallica (formerly Myceliophthora thermophila), named C1.
The C1 microorganism, which enables the development and large scale manufacture of low cost proteins, has the potential to be further developed into a safe and efficient expression system that may help speed up the development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales. Dyadic is using the C1 technology and other technologies to conduct research, development and commercial activities for the development and manufacturing of human and animal vaccines and drugs, such as virus like particles (VLPs) and antigens, monoclonal antibodies, Fab antibody fragments, Fc-Fusion proteins, biosimilars and/or biobetters, and other therapeutic proteins. Dyadic pursues research and development collaborations, licensing arrangements and other commercial opportunities with its partners and collaborators to leverage the value and benefits of these technologies in development and manufacture of biopharmaceuticals. In particular, as the aging population grows in developed and undeveloped countries, Dyadic believes the C1 technology may help bring biologic vaccines, drugs and other biologic products to market faster, in greater volumes, at lower cost, and with new properties to drug developers and manufacturers, and improve access and cost to patients and the healthcare system, but most importantly save lives.

Ahu Demir, Ph.D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Dyadic is progressing towards generating human-like glycosylation by C1 platform. Dyadic ’s research partner VTT Technical Research Centre of Finland made further progress in glycoengineering by expressing another human-like glycan (G2). The company currently generated two (G0 and G2) of the four targeted mammalian glycans (Exhibit 1).

Glycosylation is key in bioproduction. Glycosylation refers to adding a carbohydrate to a protein. Majority of biologics (over 50%) are glycosylated including antibodies and cytokines. Glycans have marked effects on therapeutic efficacy, immunogenicity, protein stability, moderation of half-life of proteins. Therefore, glycoengineering is crucial in drug development. On the way to validate C1 technology in bioproduction, glycoengineering to produce…



Get the full report on Channelchek desktop.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst
certification and important disclosures included in the full report. 
NOTE: investment decisions should not be based upon the content of
this research summary.  Proper due diligence is required before
making any investment decision.
 

Research dyadic international inc- dyai progress and efforts continues to validate c1 platform

Wednesday, February 26, 2020

Dyadic International Inc. (DYAI)

Progress and Efforts Continues to Validate C1 Platform

Dyadic International, Inc. is a global biotechnology company which is developing what it believes will be a potentially significant biopharmaceutical gene expression platform based on the industrially proven hyper productive engineered fungus Thermothelomyces heterothallica (formerly Myceliophthora thermophila), named C1.
The C1 microorganism, which enables the development and large scale manufacture of low cost proteins, has the potential to be further developed into a safe and efficient expression system that may help speed up the development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales. Dyadic is using the C1 technology and other technologies to conduct research, development and commercial activities for the development and manufacturing of human and animal vaccines and drugs, such as virus like particles (VLPs) and antigens, monoclonal antibodies, Fab antibody fragments, Fc-Fusion proteins, biosimilars and/or biobetters, and other therapeutic proteins. Dyadic pursues research and development collaborations, licensing arrangements and other commercial opportunities with its partners and collaborators to leverage the value and benefits of these technologies in development and manufacture of biopharmaceuticals. In particular, as the aging population grows in developed and undeveloped countries, Dyadic believes the C1 technology may help bring biologic vaccines, drugs and other biologic products to market faster, in greater volumes, at lower cost, and with new properties to drug developers and manufacturers, and improve access and cost to patients and the healthcare system, but most importantly save lives.

Ahu Demir, Ph.D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Dyadic is progressing towards generating human-like glycosylation by C1 platform. Dyadic ’s research partner VTT Technical Research Centre of Finland made further progress in glycoengineering by expressing another human-like glycan (G2). The company currently generated two (G0 and G2) of the four targeted mammalian glycans (Exhibit 1).

Glycosylation is key in bioproduction. Glycosylation refers to adding a carbohydrate to a protein. Majority of biologics (over 50%) are glycosylated including antibodies and cytokines. Glycans have marked effects on therapeutic efficacy, immunogenicity, protein stability, moderation of half-life of proteins. Therefore, glycoengineering is crucial in drug development. On the way to validate C1 technology in bioproduction, glycoengineering to produce…



Get the full report on Channelchek desktop.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst
certification and important disclosures included in the full report. 
NOTE: investment decisions should not be based upon the content of
this research summary.  Proper due diligence is required before
making any investment decision.
 

Research – TherapeuticsMD (TXMD) – Q4 2019 Earnings: Annovera is Now the Lead Asset in the Sales Bag

Friday, February 21, 2020

TherapeuticsMD Inc. (TXMD)

Q4 2019 Earnings: Annovera is Now the Lead Asset in the Sales Bag

(current) TherapeuticsMD, Inc. is a women’s healthcare company focused on developing and commercializing products targeted exclusively for women. It manufactures and distributes branded and generic prescription prenatal vitamins, as well as over-the-counter vitamins and cosmetics, under our vitaMedMD’ and BocaGreenMD’ brands. The company is currently developing advanced hormone therapy pharmaceutical products designed to alleviate the symptoms of and reduce the health risks resulting from menopause-related hormone deficiencies. It is also evaluating various other potential indications for our hormone technology, including oral contraception, preterm birth, vulvar and vaginal atrophy, and premature ovarian failure.

Ahu Demir, Ph.D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Annovera sales exceeded expectations and became the lead commercial focus for the company. Annovera reached $5.8 mm in the fourth quarter compared to $0.4 mm in the previous quarter. Total revenue numbers in F2019 exceeded our and street’s expectations, mainly attributed to strong Annovera sales. Thus far, the product was soft launched, the full launch is anticipated on March 1st, 2020.

Increasing our F2020 estimates primarily based on Annovera sales. We now forecast $111 mm in revenue compared to $82 mm in 2020, solely based on Annovera sales ($42 mm versus $14 mm previously). We are maintaining our F2021 forecast of $207 mm by lowering Imvexxy/Bijuva and…




Get the full report on Channelchek desktop.

This research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst
certification and important disclosures included in the full report. 
NOTE: investment decisions should not be based upon the content of
this research summary.  Proper due diligence is required before
making any investment decision.
 

Research therapeuticsmd txmd q4 2019 earnings annovera is now the lead asset in the sales bag

Friday, February 21, 2020

TherapeuticsMD Inc. (TXMD)

Q4 2019 Earnings: Annovera is Now the Lead Asset in the Sales Bag

(current) TherapeuticsMD, Inc. is a women’s healthcare company focused on developing and commercializing products targeted exclusively for women. It manufactures and distributes branded and generic prescription prenatal vitamins, as well as over-the-counter vitamins and cosmetics, under our vitaMedMD’ and BocaGreenMD’ brands. The company is currently developing advanced hormone therapy pharmaceutical products designed to alleviate the symptoms of and reduce the health risks resulting from menopause-related hormone deficiencies. It is also evaluating various other potential indications for our hormone technology, including oral contraception, preterm birth, vulvar and vaginal atrophy, and premature ovarian failure.

Ahu Demir, Ph.D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Annovera sales exceeded expectations and became the lead commercial focus for the company. Annovera reached $5.8 mm in the fourth quarter compared to $0.4 mm in the previous quarter. Total revenue numbers in F2019 exceeded our and street’s expectations, mainly attributed to strong Annovera sales. Thus far, the product was soft launched, the full launch is anticipated on March 1st, 2020.

Increasing our F2020 estimates primarily based on Annovera sales. We now forecast $111 mm in revenue compared to $82 mm in 2020, solely based on Annovera sales ($42 mm versus $14 mm previously). We are maintaining our F2021 forecast of $207 mm by lowering Imvexxy/Bijuva and…




Get the full report on Channelchek desktop.

This research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst
certification and important disclosures included in the full report. 
NOTE: investment decisions should not be based upon the content of
this research summary.  Proper due diligence is required before
making any investment decision.
 

Diabetes Panel From NobleCon16 – Type 1 Diabetes: A Functional Cure Could Be Imminent

Type 1 Diabetes: A Functional Cure Could Be Imminent
Tuesday, February 18 – 10:00am – 11:00am – Terrace Ballroom B

A medical cure, not an improved treatment, for T1D, will be the discussion by leading medical researchers in the field. Accelerated advancements that began by an unplanned meeting by two of our panelists during NobleCon14 hatched an idea that is now leading to promising clinical study results. The panel will also include a famous advocate and T1D sufferer, who is elevating the voice of those with diabetes with his national podcast. The novel approach toward a cure and clinical study results will be central to the presentation.

  • Dr. Camillo Ricordi, Director of the Diabetes Research Institute at the University of Miami School of Medicine
  • Dr. Matthias von Herrah, MD, Founder of the Type 1 Diabetes Center at La Jolla Institute for Immunology
  • Dr. Bastiano Sanna, President, and COO of Semma Therapeutics
  • Dr. Steven Perrin, CEO, and co-Founder of Anelixis Therapeutics.
  • Eric Paslay, Platinum-selling songwriter/performer, Owner of Apple Podcast Level With Me
  • Nathan Cali, Managing Director, Head of Healthcare Investment and Merchant Banking at Noble Capital Markets

Inflammasomes Panel From NobleCon16 – Inflammasome Inhibitors: The Next Generation of Innovative Immunotherapy Agents

Inflammasome Inhibitors: The Next Generation of Innovative Immunotherapy Agents

Recent breakthroughs in regulating inflammasomes will be discussed by experts on the leading edge of new discovery and therapies. Inflammatory disorders, including Alzheimer’s, inflammatory bowel disease, multiple sclerosis, Crohn’s, non-alcoholic fatty liver disease, chronic kidney disease, lupus, diabetes, and cancer, affect 5-7% of Western populations. The companies represented on this panel could potentially translate current research into future treatments.

  • Paul Ashton, PhD., Co-Founder & CEO of Inflammasome Therapeutics, Inc.
  • Gary Glick, PhD., Co-Founder & Executive Chairman of IFM Therapeutics and Michigan Professor of Chemistry
  • Steve Glover, Co-Founder, President & CEO of Zyversa Therapeutics, Inc.
  • Robert W. Keane, PhD., Professor Physiology & Biophysics, Neurological Surgery & Microbiology, and Immunology at the University of Miami, and co-founder of InflamaCore, LLC
  • Clay B. Thorp, General Partner at Hatteras Venture Partners

Cancer Panel From NobleCon16 – Cancer Treatment: Tackling the Disease Through Innovative Strategies

Cancer Treatment: Tackling the Disease Through Innovative Strategies

Current revolutionary new strategies to defeat cancer will be discussed by experts at the forefront of cancer research and treatment. The medical researchers and academic will probe into the most advanced new technologies aimed at overcoming cancer including innate immunity, modulation of tumor micro-environment, treatment of solid tumors with CAR-T, cancer vaccines and cell cycle inhibitors.

  • Dr. James Mule, Associate Center Director at Moffitt Cancer Center, member of Noble Scientific Advisory Board
  • Dr. Lauren Wood, Chief Medical Officer at PDS Biotechnology, former Clinical Director of the Vaccine Branch
  • Dr. Johannes Vieweg, Founding Dean and Chief Academic Officer at Nova Southeastern University
  • Dr. Herman Chao, CEO, Helix Biopharma
  • Dr. Mark Erlander – Chief Scientific Officer of Trovagene
  • Dr. John A. Scarlett – Chairman and CEO of Geron Corp
  • Cosme Ordonez, MD, PhD, (Moderator) Noble Capital Markets, Director of Life Sciences Research

Type 1 Diabetes: A Functional Cure Could Be Imminent

Type 1 Diabetes: A Functional Cure Could Be Imminent
Tuesday, February 18 – 10:00am – 11:00am – Terrace Ballroom B

A medical cure, not an improved treatment, for T1D, will be the discussion by leading medical researchers in the field. Accelerated advancements that began by an unplanned meeting by two of our panelists during NobleCon14 hatched an idea that is now leading to promising clinical study results. The panel will also include a famous advocate and T1D sufferer, who is elevating the voice of those with diabetes with his national podcast. The novel approach toward a cure and clinical study results will be central to the presentation.

  • Dr. Camillo Ricordi, Director of the Diabetes Research Institute at the University of Miami School of Medicine
  • Dr. Matthias von Herrah, MD, Founder of the Type 1 Diabetes Center at La Jolla Institute for Immunology
  • Dr. Bastiano Sanna, President, and COO of Semma Therapeutics
  • Dr. Steven Perrin, CEO, and co-Founder of Anelixis Therapeutics.
  • Eric Paslay, Platinum-selling songwriter/performer, Owner of Apple Podcast Level With Me
  • Nathan Cali, Managing Director, Head of Healthcare Investment and Merchant Banking at Noble Capital Markets

Inflammasome Inhibitors: The Next Generation of Innovative Immunotherapy Agents

Inflammasome Inhibitors: The Next Generation of Innovative Immunotherapy Agents

Recent breakthroughs in regulating inflammasomes will be discussed by experts on the leading edge of new discovery and therapies. Inflammatory disorders, including Alzheimer’s, inflammatory bowel disease, multiple sclerosis, Crohn’s, non-alcoholic fatty liver disease, chronic kidney disease, lupus, diabetes, and cancer, affect 5-7% of Western populations. The companies represented on this panel could potentially translate current research into future treatments.

  • Paul Ashton, PhD., Co-Founder & CEO of Inflammasome Therapeutics, Inc.
  • Gary Glick, PhD., Co-Founder & Executive Chairman of IFM Therapeutics and Michigan Professor of Chemistry
  • Steve Glover, Co-Founder, President & CEO of Zyversa Therapeutics, Inc.
  • Robert W. Keane, PhD., Professor Physiology & Biophysics, Neurological Surgery & Microbiology, and Immunology at the University of Miami, and co-founder of InflamaCore, LLC
  • Clay B. Thorp, General Partner at Hatteras Venture Partners

Cancer Treatment: Tackling the Disease Through Innovative Strategies

Cancer Treatment: Tackling the Disease Through Innovative Strategies

Current revolutionary new strategies to defeat cancer will be discussed by experts at the forefront of cancer research and treatment. The medical researchers and academic will probe into the most advanced new technologies aimed at overcoming cancer including innate immunity, modulation of tumor micro-environment, treatment of solid tumors with CAR-T, cancer vaccines and cell cycle inhibitors.

  • Dr. James Mule, Associate Center Director at Moffitt Cancer Center, member of Noble Scientific Advisory Board
  • Dr. Lauren Wood, Chief Medical Officer at PDS Biotechnology, former Clinical Director of the Vaccine Branch
  • Dr. Johannes Vieweg, Founding Dean and Chief Academic Officer at Nova Southeastern University
  • Dr. Herman Chao, CEO, Helix Biopharma
  • Dr. Mark Erlander – Chief Scientific Officer of Trovagene
  • Dr. John A. Scarlett – Chairman and CEO of Geron Corp
  • Cosme Ordonez, MD, PhD, (Moderator) Noble Capital Markets, Director of Life Sciences Research

Renaissance in Inflammasome Therapeutics

Noblecon16  Panel is set to Discuss Recent Breakthroughs in Inflammasome Space

There is an ongoing renaissance in the potential for drugs targeting a unique inflammation hub, inflammasome. Inflammasomes are crucial to coordinate in?ammatory responses.  Inflammation is a protective immune response to harmful stimuli, such as pathogens, dead cells or irritants, and is tightly regulated by the host. The innate immunity is the first line of defense in recognition of infection and initiation of clearance by the host. The activation of the inflammasome is a key function mediated by the innate immune system. Three main domains comprise inflammasomes: sensor molecule, adaptor protein (ASC), and effector protein mainly pro-caspase 1.

Oligomerization (generation of multi-molecular complex of inflammasome) is triggered by danger associated molecular patterns (DAMPs) or pathogen-associated molecular patterns (PAMPs) that results in effector activation and leading to maturation of procytokines and pyroptosis, a form of inflammatory cell death. The nucleotide-binding domain-like receptor (NLR) family is the main group of proteins considered as inflammasome sensors. Inflammasome sensor proteins are involved in the recognition of particular danger stimulus and then initiate the assembly of inflammasome multimeric complex. Among NLR family (NLRs—NLRP1, NLRP2, NLRP3, and NLRC4, nonNLRs—absent in melanoma 2 (AIM2) and pyrin), NLRP3 recognizes the largest array of stimulus and it is the most studied in terms of developing NLR inhibitors. The adaptor proteins are known as apoptosis-associated speck-like protein (ASC) containing a caspase activation and recruitment domain (CARD). In response to PAMPs or DAMPs, the sensor molecule recruits ASC, which recruits pro-caspase 1. This interaction converts pro-caspase-1 into its activated form, caspase-1. Caspase-1 then cleaves the proforms of IL-1ß and IL-18 into their mature forms, which triggers the inflammatory process, which can induce cell death via a process known as pyroptosis (Exhibit 1). The release of IL-1ß and IL-18 leads to the activation of several downstream pathways that further assist in the inflammatory process.

Exhibit 1. The inflammasome mechanism of action

Source:
Hoffman and Broderick, J Allergy Clin Immunol, 2016

While insufficient inflammation can lead to persistent infection of pathogens, excessive inflammation can cause chronic or systemic inflammatory diseases. Inflammasomes play a crucial role in mediating inflammation and therefore serve as potential drug targets for the treatment of inflammatory-mediated diseases. Inflammasomes have been associated with variety of autoinflammatory and autoimmune diseases, including neurodegenerative diseases (multiple sclerosis, Alzheimer’s disease, and Parkinson’s disease) and metabolic disorders (atherosclerosis, type-2 diabetes, and obesity). Currently, there are no approved inflammasome inhibitors; however, there are several early stage assets in the pipeline. While most companies are targeting the sensor molecule (NLRP3), some others are taking a unique approach targeting either the adaptor protein (ASC) or other molecules.

 

Exhibit 2. Recent selected deals in inflammasome space

At least, four biotechnology firms with NLRP3 inhibitors have been founded in the last four years. In 2018, they raised a collective $117 million in venture capital. Inflazome was recently granted over US$1M in funding from The Michael J. Fox Foundation for Parkinson’s Research (MJFF). High activity in inflammasome space was seen in the recent years. Among the multiple M&A and partnership deals, the majority of them were at preclinical stage. The transaction volume varied, $160 mm – $1.6 billion (Exhibit 2). Multiple acquisitions in the field show the first inflammasome target -NLRP3 -is gaining momentum. The question remains how fast the best set of indications can be identified from the sea of possibilities.

Selected Companies Targeting Inflammasome

Highlighted below the Inflammasome Panel
attendees and selected companies with current programs in inflammasome
therapeutics (alphabetical order).

Inflammasome Inhibitors: The Next Generation of
Innovative Immunotherapy Agents
Monday, February 17 – 10:00am – 11:00am – Terrace Ballroom B

  • Paul Ashton, PhD., Co-Founder & CEO of Inflammasome Therapeutics, Inc.
  • Gary Glick, PhD., Co-Founder & Executive Chairman of IFM Therapeutics and Michigan Professor of Chemistry
  • Steve Glover, Co-Founder, President & CEO of Zyversa Therapeutics, Inc.
  • Robert W. Keane, PhD., Professor Physiology & Biophysics, Neurological Surgery & Microbiology, and Immunology at the University of Miami, and co-founder of InflamaCore, LLC
  • Clay B. Thorp, General Partner at Hatteras Venture Partners

IFM Therapeutics (Private
company)

IFM Therapeutics (IFM) is a Boston-based, a privately held biopharmaceutical company focused on developing novel therapies that regulate the innate immune system. IFM was formed following the acquisition of the original IFM Therapeutics by Bristol-Myers Squibb in 2017 ($1.3 billion). IFM has a unique approach in regulating the management of its research and development activities. IFM has separate subsidiaries that are responsible for a particular set of programs. While each subsidiary is financially independent, they share common infrastructure and resources. IFM has established three subsidiaries: IFM Tre was launched in July 2018 and was subsequently acquired by Novartis in May 2019, IFM Due, which launched in February 2019, and the most recent, IFM Quattro launched in Dec 2019.

 IFM’s inflammasome platform is based on antagonists of NLR proteins for inflammation-mediated diseases (such as, Alzheimer’s, liver fibrosis/non-alcoholic steatohepatitis (NASH), and type 2 diabetes) and anti-cancer agents for modulating the tumor environment. IFM currently has two NLRP3 antagonists in the preclinical stage and one NLRP3 antagonist in Phase 1 for the treatment of inflammation, fibrosis, neuroinflammation. The rights of the above molecules belong to Novartis. IFM has another NLRP3 agonist, an anti-cancer agent, owned by Bristol-Myers Squibb.

Inflammasome Therapeutics
(Private company)

Inflammasome therapeutics is developing therapies for Alzheimer’s, multiple sclerosis, macular degeneration, and type 2 diabetes by averting unusual inflammasome activation. They have identified and licensed a series of molecules known as Kamuvudines. The company has presented and published favorable preclinical data and recently established partnership with Boehringer Ingelheim to co-develop up to three therapies for patients with retinal diseases. Based on the agreement, Inflammasome is entitled to receive up to $160 million in up-front, research and development support and milestone payments and royalties based on future commercial sales of the products.

Inflazome (Private company)

Inflazome is a clinical stage biotechnology company that specializes in developing a NLRP3 small-molecule targeting inflammatory mediated diseases. The company received a grant in October 2019 from The Michael J. Fox foundation for the development of a NLRP3-specific Positron Emission Tomography (PET) tracer to allow non-invasive imaging of inflammasome-driven inflammation in the brain. Inflazome also completed a $46 million Series B funding in 2018. Inflazome’s lead asset Inzomelid is a potent, selective, brain penetrant NLRP3 inhibitor that is currently in Phase Ib trials. Inzomelid is indicated for the treatment of neuroinflammatory and neurodegenerative diseases such as Parkinson’s, Alzheimer’s and Motor Neuron Disease as well as the orphan disease CAPS. The second is Somalix, a potent, selective, peripherally restricted NLRP3 inhibitor that is currently in Phase I trials indicated for the treatment of arthritis and cardiovascular diseases. Clinical trial data are not available at this time.

Nodthera (Private company)

Nodthera is an early-stage biopharmaceutical company developing novel NLRP3 inhibitors for the treatment of NASH, pulmonary fibrosis, neurodegenerative disorders, and inflammatory bowel disease (IBD). The company’s lead candidate NT-0167 is currently under pre-IND stage. Nodthera completed a $40 million Series A funding in 2018.

Zyversa Therapeutics, Inc (Private
company
)

Zyversa is a clinical stage biopharmaceutical company developing first-in-class therapeutics for inflammatory (e.g., multiple sclerosis and NASH) and renal (e.g., diabetic nephropathy and lupus nephritis) diseases. Zyversa’s lead inflammasome targeting agent is IC 100, a monoclinal antibody targeting ASC for the treatment of multiple sclerosis. The company licensed IC 100 from InflamaCORE. Preclinical studies suggest that IC 100 inhibits the downstream inflammatory pathways. IC 100 is a nonspecific ASC inhibitor, which has a wide therapeutic range potentially inhibiting various types of inflammasomes. Zyversa has three additional ASC inhibitors under development for Lupus Nephritis, NASH, and diabetic kidney disease.